ZELTIQ CoolSculpting System User manual

ZELTIQ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton, CA 94588 USA
[phone]
www.coolsculpting.com
ZELTIQ Customer Service
Worldwide: ([phone]
USA: ([phone]
(1-888-ZELTIQ1)
User Manual
BRZ-101-TUM-EN2-L
CoolSculpting System
(ZELTIQ Breeze System)

2 BRZ-101-TUM-EN2-L
Preface
Contents
•Intellectual Property......................................................................... 2
•Indications for Use............................................................................ 2
•Contraindications ............................................................................. 3
•Warnings........................................................................................... 3
•Treatment Sites ................................................................................ 4
•Precautions....................................................................................... 5
•Adverse Events ................................................................................. 5
•About the System ............................................................................. 6
•Freeze Detect System....................................................................... 6
•ZELTIQ Clinical Studies...................................................................... 7
•System Symbols.............................................................................. 18
•User Documentation ...................................................................... 20
Intellectual Property
Copyright©2018 ZELTIQ Aesthetics, Inc. All rights reserved. Unauthorized duplication or use is prohibited.
COOLSCULPTING®, ZELTIQ®, and FREEZE DETECT®are registered trademarks of ZELTIQ Aesthetics, Inc. The
procedures described in this document are covered by U.S. Patent 7,367,341. Additional issued patents and
patent applications pending worldwide relate to the products and procedures described in this document. For
complete information on patents, go to http://www.coolsculpting.com/about-zeltiq/patents/
Your system may be labeled as the CoolSculpting®System, ZELTIQ®System, ZELTIQ®Breeze System, or the
ZELTIQ®Lipolysis System.
Indications for Use
The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis
(breakdown of fat) of the upper arm, bra fat, back fat, banana roll, thigh, abdomen, and flank, or “love
handles”in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for cold-
assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. The device
is intended to affect the appearance of visible fat bulges in the upper arm, bra fat, back fat, banana roll,
submental and submandibular areas, thigh, abdomen and flank. When used for cold-assisted lipolysis of the
submental area, the device can also affect the appearance of lax tissue in the submental area.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological
treatments and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to
minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle
spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain,
and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of
cellulite.
The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device with a patient’s
skin by mitigating minor variances in device-to-skin contact.
In the United States of America, Federal law restricts this device to sale by or on the order of a
physician.

System Overview Contraindications
User Manual 3
Contraindications
Localized skin cooling is contraindicated in patients who have:
•Cryoglobulinemia
•Cold agglutinin disease
•Paroxysmal cold hemoglobinuria
Warnings
Unauthorized modification or repair of the control unit, its components, or supplies may result in unsafe
conditions and/or impaired performance. No modification of this equipment is allowed without express
authorization from ZELTIQ. Any unauthorized modification or repair will void the warranty.
CoolSculpting System use has not been studied in children, those who are pregnant or lactating, or patients
with:
•Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or Chilblains (pernio)
•Known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol
•Impaired peripheral circulation in the area to be treated
•Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy
•Impaired skin sensation
•Open or infected wounds
•Bleeding disorders or concomitant use of blood thinners
•Recent surgery or scar tissue in the area to be treated
•Hernia in or adjacent to the treatment site
•Skin conditions such as eczema, dermatitis, or rashes in the area to be treated
The effect of performing a CoolSculpting treatment (treatment) with a vacuum applicator on a patient who has
a hernia in or adjacent to the treatment site has not been studied. The applicator uses vacuum pressure to
draw tissue into the applicator cup during the treatment. The vacuum pressure may therefore apply pressure
on a pre-existing hernia or pre-existing structurally weak area such as a surgical scar, causing further
complications. Physicians should examine that patient for evidence of pre-existing abdominal or femoral hernia
prior to use of the device.
The system operates at temperatures below 0°C, which can freeze tissue; clinical events that are common to
freezing tissue should be considered.
The use of this device on areas with superficially located nerve branches, arteries, or veins has not been
demonstrated to be safe and effective. Such use may result in injury to the patient.
The effect of performing treatments directly over active implanted devices, such as pacemakers and
defibrillators, is not known.
Patients with chronic pain, sensitivity to cold, or an anxiety disorder may be more prone to pain or discomfort
during the treatment.
Do not use the CoolSculpting System of areas with a subcutaneous fat layer thickness of less than 1cm.
Do not use the CoolSculpting System on areas of decreased sensation or perfusion.
Do not use the CoolSculpting System on areas with minimal underlying muscle mass or on areas with
superficially located nerve branches, arteries, or veins.
Do not use the CoolSculpting System on the face, head, genitalia, inguinal creases, axillae, popliteal fossae,
antecubital fossae, hands, or feet.

Treatment Sites System Overview
4 BRZ-101-TUM-EN2-L
The use of other electronic medical devices on a patient who is undergoing a treatment might interfere with
the correct functioning of the system, possibly resulting in injury to the patient. Do not use other electronic
medical devices on a patient who is undergoing a treatment.
Treatment Sites
Observe the following warnings when treating the submental and submandibular areas:
Treatment Site
Warning
WARNING: Cold exposure to the
hypoglossal nerve may cause tongue
deviation following treatment of the
submental and submandibular areas.
Hypoglossal Nerve
WARNING: Cold exposure to the marginal
mandibular nerve may cause lower lip
weakness following treatment of the
submental and submandibular areas.
Marginal Mandibular Nerve
WARNING: Cold exposure to the
submandibular gland may cause
xerostomia, or decrease in saliva
production, following treatment of the
submental and submandibular areas.
Submandibular Gland
Table 1: Submental and Submandibular Areas Treatment Warnings

System Overview Precautions
User Manual 5
Observe the following warning when treating the upper arm:
Treatment Site
Warning
WARNING: Avoid compression of the ulnar
nerve during treatment of the upper arm.
Ulnar Nerve
Table 2: Upper Arm Treatment Warning
Precautions
The system is intended for use by a trained physician or a physician-designated medical professional.
If the operator observes a potential safety issue or operational abnormality during use, the treatment should
be terminated and ZELTIQ Customer Service should be contacted promptly.
The use of other equipment and supplies with the system has not been tested and may cause unexpected
results.
Adverse Events
Common Adverse Events
The following effects can occur in the treatment area during and after a treatment. These effects are
temporary and generally resolve within days or weeks.
During a treatment:
•Sensations of pulling, tugging, and mild pinching at the treatment site.
•Intense cold, tingling, stinging, aching, cramping. These sensations subside as the area becomes numb.
Immediately after a treatment:
•Redness and firmness.
•Transient blanching and/or mild bruising around the edges of the treatment area.
•Tingling and stinging.
One to two weeks after a treatment:
•Redness, bruising, and swelling.
•Tenderness, cramping, and aching.
•Itching, skin sensitivity, tingling, and numbness. Numbness can persist up to several weeks after a
treatment.
•Sensation of fullness in the back of the throat after submental area treatment.
Rare Adverse Events
•Paradoxical hyperplasia: Visibly enlarged tissue volume within the treatment area, which may develop two
to five months after treatment. Surgical intervention may be required.
•Late-onset pain with a typical onset several days after a treatment and resolution within several weeks.

About the System System Overview
6 BRZ-101-TUM-EN2-L
•Frostbite: First- and second-degree frostbite may occur during treatment. It typically resolves without
sequelae with proper care.
•Vasovagal symptoms: Dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or
immediately after the treatment.
•Subcutaneous induration: Generalized hardness and/or discrete nodules within the treatment area, which
may develop after the treatment, and may present with pain and/or discomfort.
•Hyperpigmentation: Hyperpigmentation may occur after treatment. Typically, it resolves spontaneously.
•Hernia: Treatment may cause new hernia formation or exacerbate pre-existing hernia, which may require
surgical repair.
•Treatment Area Demarcation (TAD): An aesthetic outcome of treatment in which the patient experiences
excessive fat removal in the treatment area, resulting in a visible disruption to the continuous contour of
fat, or unwanted indentation in the treated area.
•Cold panniculitis: Cold panniculitis results from injury to adipose tissue exposed to cold and may result in a
mild to severe inflammatory response. In mild cases, the symptoms are self-resolving and may include
redness, swelling, skin nodules, warmth, tenderness, and possible low-grade fever. These cases typically
resolve without long-term sequelae. In more severe cases, an intense inflammatory response may result in
more extensive tissue damage, including fat necrosis, which may require medical or surgical intervention.
Frostbite, vasovagal symptoms, sensation in the back of the throat during swallowing, and hyperpigmentation
were observed during clinical trials, while the others were reported in post market use.
WARNING: Before using the system, read and understand the User Documentation set (User Documentation
on page 19).
About the System
The system is comprised of a control unit, a surface or vacuum applicator, massage function and supplies such
as cards, foam borders, gelpads, liners, pretreatment skin wipes, and securement systems. The applicators,
foam borders, gel, gelpads, liners, pretreatment skin wipes, and securement systems are patient-applied parts.
During a treatment, the operator applies a gel/gelpad and applicator to the patient’s skin. The vacuum
applicator draws tissue into the applicator cup and holds the tissue against the cooling surfaces of the
applicator; the surface applicator does not use vacuum pressure. The operator starts the treatment. Sensors in
the cooling surfaces of the applicator monitor the skin surface, providing feedback that controls the rate of
heat flux. The gel/gelpad protects the skin by providing thermal coupling at the interface between the cooling
surfaces of the applicator and the skin. The card provides cycles and profiles for use with the system.
Freeze Detect System
The system operates at temperatures below 0°C, which can freeze tissue. Therefore, the system monitors
tissue during cooling and employs multiple safety features including the Freeze Detect®system, to minimize the
risk of damage to tissue. In spite of these measures, on rare occasions, the Freeze Detect system can detect a
possible freeze condition.
The Freeze Detect system is comprised of several features, including thermal sensors and proprietary
algorithmic software. Freeze Detect is an integral part of the CoolSculpting System and is automatically
employed when a treatment is initiated. When the Freeze Detect system detects a possible freeze condition, it
stops the treatment and displays a Z409 message. If you receive this message, remove the applicator and
gelpad or gel, and assess the tissue before taking further action. If you receive a second Z409 message for one
treatment site, discontinue the treatment. Failure to follow instructions could result in injury to the patient,
including first- or second-degree burns. Second-degree burns or complications of second-degree burns may
result in hypopigmentation.
ZELTIQ Clinical Studies

System Overview ZELTIQ Clinical Studies
User Manual 7
NOTE: When the flank, abdomen, and thigh studies were performed, the degree of cooling or warming during a
treatment was expressed as the Cooling Intensity Factor (CIF). The CIF was an index that represented the rate
of heat flux into or out of tissue relative to 37°C. A positive CIF described the rate of heat flux out of tissue. A
negative CIF referred to the rate of heat flux into tissue. The studies in this section used the CIF as a unit of
measure. Current treatment parameters refer to the temperature at the surface of the applicator.
The ZELTIQ CoolSculpting System has undergone pre-clinical and clinical investigation (data on file at ZELTIQ).
The clinical investigation and results pertaining to skin cooling for fat layer reduction in submental and
submandibular areas, abdomen, flanks, thighs, and alternate treatment parameters are summarized in this
section.
The below table summarizes the efficacy information for each study that has been conducted. Further details
on each study can be found in the individual summaries below.
Treatment Site
Photographic Review
Results (% correct)
Ultrasound Results (mean
reduction in mm)
Subject Satisfaction
(% satisfied)
Flanks
88.6
N/A
82.1
Abdomen
85.3
1.9
62
Inner thigh
90.5
2.8
93.3
Outer thigh
83.9
2.5
86.5
Modified treatment parameters
85
3.92
88.37
Submental Area
91.4
2.0
83.3
Upper Arm
85.2 [72.9%, 93.4%]
3.2
63.3
Flank Study
Assessment Time Line
A clinical study that enrolled 60 healthy adult subjects, aged 23 to 65 years at two clinical centers was
conducted from August 2007 through June 2008. Each individual received one or more applications of the
ZELTIQ CoolSculpting System with a ZELTIQ vacuum applicator. Assessments of treatment efficacy and safety
were performed as follows:
Day 0 Treatment
1 Week
2 Months
6 Months
Consent Screening
Photographs Ultrasound Baseline Demographics Clinical Assessment
Phone Follow-up Clinical Assessment
Photographs Ultrasound Clinical Assessment
Photographs Ultrasound Clinical Assessment
Four groups were treated with the treatment regimens shown in Table 3. A short period (two to five minutes)
of simultaneous tissue cooling and massage was used during each treatment to facilitate lipolysis. For each
subject, the larger of the two flank bulges was treated, leaving the contralateral side as an untreated control.

ZELTIQ Clinical Studies System Overview
8 BRZ-101-TUM-EN2-L
Treatment
Group
Number of
Subjects
Cooling
Intensity Factor
(CIF)
Temperature
Cooling
Duration
(minutes)
Energy Extraction
Rate (mW/cm2)
1
28
33
-4ºC
60 min
63.6
2
11
37
-7ºC
30 min
68.3
3
11
37
-7ºC
45 min
68.3
4
10
42
-10°C
30 min
72.9
Table 3: Treatment Regimens
Clinical Efficacy Results
Blinded Photographic Evaluation
Efficacy was determined by photographic evaluation, ultrasound fat-thickness measurements, clinical
assessments, and subject satisfaction. A blinded photographic evaluation was performed of 50 evaluable
subjects in which three blinded reviewers were provided two series of photographs for each subject, one series
taken at baseline, and the other taken post-treatment. Each reviewer was asked to identify the baseline photo
series independently. In the blinded photographic review of all subjects the reviewers correctly identified the
baseline photo series 88.6% of the time.
Treatment
Group
Number of Subjects
All Data
% Correct ± % SE
All Data
p-values
All Groups
50
88.6 ± 4.1
< 0.001*
Group 1
20
90.7 ± 5.1
< 0.001*
Group 2
10
90.0 ± 9.5
< 0.005*
Group 3
11
90.9 ± 8.7
< 0.001*
Group 4
9
66.7 ± 15.7
< 0.4
Table 4: Independent Photo Review Results
Post-treatment ultrasound measurements of fat layer thickness were compared with baseline measurements,
using the untreated control side to normalize for weight changes that may have occurred during the follow-up
period. The fat layer reduction as measured with ultrasound averaged 18.7% from baseline, after being
normalized by the untreated control side. Ultrasound measurements at two months and at six months indicate
that on average, 75% of the total fat layer reduction for a subject was realized within two months of treatment.
Overall, 82.1% of subjects enrolled in the study indicated they were satisfied with the treatment.
Clinical Safety Results
Reported side effects included pain during or post-treatment, minor or significant bruising of the treated area,
temporary hypoesthesia, tingling, erythema, and edema. All side effects during this study resolved
spontaneously, most resolved within hours or days of the treatment.
Resolution of Hypoesthesia
Partial numbness and, to a lesser extent tingling, over the skin of the application site were reported for all
subjects immediately post-treatment and for 68% of subjects by one week post-treatment. Partial numbness or
tingling is a temporary and anticipated effect of the treatment and was found to resolve without intervention
within two to three weeks on average, although in 8.3% of the cases these effects endured for as long as two
months.

System Overview ZELTIQ Clinical Studies
User Manual 9
Adverse Events
There were four relatively minor adverse events; each was anticipated and resolved without intervention.
During treatment, two adverse events were reported involving pain and/or discomfort. Each of these resolved
after treatment was discontinued. Following treatment, two adverse events were reported: severe bruising and
minor cramping or muscle spasm in the treatment area. Both resolved without intervention within four weeks.
None of the adverse events reported during this study was considered serious or unanticipated.
During the clinical investigation, serum lipids and liver enzymes were measured in a subset of 20 subjects at
times from 1 week to 12 weeks post-treatment to determine whether the CoolSculpting treatment had an
effect on clinical chemistry. The following analytes were measured: Cholesterol, Triglycerides, HDL Cholesterol,
LDL Cholesterol, VLDL Cholesterol, Cholesterol/HDL Ratio, Total Protein, Albumin, AST-SGOT, ALT-SGPT, Total
Bilirubin, and Direct Bilirubin. No statistically significant changes were found for serum lipids or liver enzyme
data from baseline over the duration of the study.
BMI Recommendations
For best results, patients should have a BMI of 30 or less and should maintain a healthy lifestyle following a
treatment. The study evaluations for this clinical investigation included subjects with a Body Mass Index up to
38.7; however, patients who are significantly overweight are less likely to appreciate a significant improvement
with a single treatment.
Skin Type
The clinical investigation subject population included Fitzpatrick skin types ranging from I to VI, with the
majority of subjects being types II to IV. No change in skin pigmentation was observed following a treatment.
Based on the clinical data, ZELTIQ recommends that practitioners read this Preface carefully and pay special
attention to warnings and cautions throughout the User Manual and Directions for Use.
Abdominal Study
A separate clinical investigation with the CoolSculpting device on the fat layer of the abdomen resulted in a
clinically measurable reduction of local subcutaneous fat of the abdomen, in the same manner that that was
previously demonstrated for the flank. Treatments were performed at -10°C (CIF 42) for 60 minutes. The
primary endpoint results (Independent Photo Review) revealed that the percent correct identification of the
pre-treatment images exceeded the pre-established 80% criterion and is statistically significant. Fat layer
reduction in the treated area of the abdomen was further documented by ultrasound imaging which also
revealed a statistically significant and clinically relevant reduction. Overall, 62% of subjects enrolled in the
study indicated they were satisfied with the treatment.
Study data also revealed that the treatment is as safe when used in the abdomen as previously tested for the
flank. Data collected during the study demonstrated that the post-treatment lipid profile and liver function
tests showed no statistically significant difference from baseline. This was true for mean values for the entire
population as well as for each individual subject. No serious adverse events were reported during the abdomen
study. The results of this clinical study provide supportive evidence that treatment with the CoolSculpting
device provides consistent and clinically significant reduction of the fat layer of the abdomen.
Summary of Thigh Studies
ZELTIQ conducted two clinical investigations to determine the safety and efficacy of cold-assisted lipolysis in
the thigh region. In the inner thigh study, 90 treatments were completed with the flat cup vacuum applicator at
-10°C (CIF 42); in the outer thigh study, 40 treatments were completed with the belt applicator at -10°C (CIF
23). Follow-up data is available for both studies up to 16 weeks post-treatment. Three blinded evaluators
assessed the photos for visible reduction of fat in the treatment areas at the 16 -week follow-up visit. The
evaluators were presented with the series of photographs and were asked to identify the pre-treatment
photographs for each subject.

ZELTIQ Clinical Studies System Overview
10 BRZ-101-TUM-EN2-L
The overall correct identification rate by the three evaluators was 90.5% for the inner thigh study and 83.9%
for the outer thigh study. At least two out of three evaluators correctly identified 90.5% of all photo pairs for
the inner thigh study and 87.1% for the outer thigh study. The results demonstrate that the ZELTIQ
CoolSculpting System affects the appearance of the thighs.
Change in subcutaneous fat layer thickness was also measured by ultrasound at 16-weeks: In the inner thigh
study average fat thickness change was a 2.7 mm decrease. In the outer thigh study average fat thickness
change was a 2.6 mm decrease. Overall for the inner thigh study, 93.3% of subjects enrolled in the study
indicated they were satisfied with the treatment. Overall for the outer thigh study, 86.5% of subjects enrolled
in the study indicated they were satisfied with the treatment.
Adverse events reported during the studies included numbness and mild contour irregularity. All adverse
events but one resolved by the 16 week follow-up. A mild case of hyperpigmentation in the treatment area
persisted beyond the 16 week follow-up. This is an adverse event that typically resolves spontaneously. The
clinical investigations demonstrate that use of the ZELTIQ CoolSculpting System can safely and effectively
induce cold-assisted lipolysis in the thigh in the same manner as in the abdomen and flanks.
Summary of Study with Modified Treatment Parameters
A study of a modified treatment parameter was designed to evaluate the safety and efficacy of the
CoolSculpting System with a colder, shorter treatment. In this study, 63 treatments were completed with the
CoolCurve+ applicator on 45 subjects. Each subject received one or two non-overlapping unilateral vacuum
treatments of the flank at a treatment temperature of -15°C for 45 minutes; immediately after each treatment,
the treated tissue was massaged manually for two minutes. Follow-up data is available for up to 16 weeks post-
treatment.
Subject safety was assessed throughout the study, including immediately post-treatment, one-week post-
treatment telephone follow-up, and at 8- and 16-week post-treatment clinic visits. The primary safety endpoint
was the occurrence of device- or procedure-related adverse events. No serious adverse events were reported
during the study or 16-week follow-up period. Adverse events reported during the study included mild
numbness, post-treatment pain, hyperpigmentation, subcutaneous induration, and first-degree burn in the
treatment area. All but three adverse events resolved by the 16 week follow-up. Three subjects reported mild
numbness at the 16-week follow-up; all three reported resolution within the next 19 calendar days.
The primary efficacy endpoint was the change in fat layer thickness as measured with ultrasound. Fat layer
reduction in the treated area of the flank was documented by ultrasound imaging pre-treatment and at 8 and
16 weeks post-treatment. Subsequent evaluation of the ultrasound images revealed a statistically significant
and clinically relevant reduction.
Secondary efficacy endpoints included correct identification of pre- and post-treatment images by three
blinded independent reviewers, and subject satisfaction assessment by subject questionnaire. Photos taken at
baseline and at the 16-week follow-up visits were reviewed by a blinded independent panel of three physicians
board-certified in dermatology or plastic surgery. The overall correct identification rate by the three evaluators
was 85%, which exceeded the pre-established 80% criterion and is statistically significant.
The secondary efficacy endpoint for subject satisfaction was performed by means of a questionnaire with
questions about the comfort and subjective results of the treatment, and about the subject’s attitudes toward
CoolSculpting after treatment. With the exception of comfort, the majority of responses were positive to very
positive. Overall, 88.37% of subjects enrolled in the study indicated they were satisfied with the treatment.
These clinical findings demonstrate that use of the CoolSculpting System can safely and effectively induce cold-
assisted lipolysis with colder temperatures down to -15°C for shorter duration treatments with vacuum and
surface applicators.
Submental Area Study
ZELTIQ conducted a clinical investigation to determine the safety and efficacy of the CoolSculpting System for
affecting the appearance of visibly localized subcutaneous fat localized in the submental area.