# K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System

- Pathway: 510(k) (Special)
- Applicant: C2 Therapeutics, Inc.
- Decided: Jul 7, 2015 after 78 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K840536 (1984). 13 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131523: Cryoballoon Focal Ablation System, C2 Therapeutics (2013) Summary page 4.

## Most influential descendants
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), 6 descendants of its own
- K161202: C2 Cryoballoon Ablation System (2017), 5 descendants of its own
- K163684: C2 CryoBalloon Ablation System (2018), 4 descendants of its own
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2019), 3 descendants of its own
- K203024: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2020), 2 descendants of its own

## Indications for use
The Coldplay CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

Source page: https://510kreport.com/device/K151054
Methodology: https://510kreport.com/methodology