# K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System

- Pathway: 510(k) (Traditional)
- Applicant: C2 Therapeutics, Inc.
- Decided: Apr 13, 2016 after 239 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 67 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 74 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.
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System, C2 Therapeutics, Inc. (2015) Summary page 4.
- K143625: truFreeze System, CSA Medical, Inc. (2015) Summary page 4.
- K083737: Halo Ablation Catheter, Barrx Medical, Incorporated (2009) Summary page 4.

## Most influential descendants
- 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
- K212814: C2 CryoBalloon Ablation System (2021), 1 descendant of its own

## Recalls of this device
- Jan 6, 2017 · Class II · Z-1477-2017: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.

## Indications for use
The Coldplay CryoBalloon™ Focal Ablation System, Coldplay CryoBalloon™ Full Ablation System, and Coldplay CryoBalloon™ Swipe Ablation System are intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with high grade dysplasia.

Source page: https://510kreport.com/device/K152329
Methodology: https://510kreport.com/methodology