C2 CryoBalloon FG-1017

GUDID 00854924006170

Controller

C2 THERAPEUTICS, INC.

General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 00854924006170
• NIH Device Record Key: 01d251bf-21c3-48d8-9ead-48f3e593eb19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C2 CryoBalloon
• Version Model Number: FG-1017
• Catalog Number: FG-1017
• Company DUNS: 929139249
• Company Name: C2 THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854924006170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160994

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-08

On-Brand Devices [C2 CryoBalloon]

• 00854924006316: 180 Standard Catheter 30-mm
• 00854924006309: 90 Standard Catheter 30-mm
• 00854924006286: Focal Standard Catheter 30-mm
• 00854924006279: 180 Pear Catheter
• 00854924006262: 90 Pear Catheter
• 00854924006248: Pear Catheter Focal
• 00854924006187: Foot Pedal
• 00854924006170: Controller