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C2 Therapeutics receives FDA 510(k) clearance for Coldplay Cryoballoon full and swipe ablation systems

C2 Therapeutics, a privately held company founded to improve treatment of precursors to esophageal cancer (Barrett’s Esophagus or BE), announced US Food and Drug Administration (FDA) 510(k) clearance for the Coldplay Cryoballoon Full Ablation System and the Coldplay Cryoballoon Swipe Ablation System.

"The clearance of Coldplay Cryoballoon Full and Swipe Systems is an important milestone in broadening the company’s portfolio," said Peter Garcia-Meza, President and CEO of C2 Therapeutics.

"The Full and Swipe Ablation Systems will be critical in allowing physicians to ablate larger areas of tissue in endoscopic applications."

"The US regulatory clearance of the promising Coldplay Full and Swipe Ablation Systems is a major leap forward in the care of patients with Barrett’s Esophagus at risk for development of esophageal cancer," said George Triadafilopoulos, MD, Clinical Professor of Gastroenterology and Hepatology, Stanford University, Stanford, CA. "These technologies provide endoscopists with more options to eliminate Barrett’s Esophagus and improve patient outcomes."

Barrett’s Esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett’s Esophagus), putting patients at greater risk of developing cancer of the esophagus.

C2 Therapeutics was founded in 2007 to address the limitations of current Barrett’s Esophagus treatment options.

Headquartered in Redwood City, California, C2 is a privately held company whose Coldplay Cryoballoon Ablation Systems set a new standard for simplicity in the endoscopic ablation of Barrett’s Esophagus.

The technology comprises a through-the-scope, highly compliant balloon catheter that is simultaneously inflated and cooled by an inert refrigerant delivered through a small disposable handheld unit. Operation is intuitive, fast and cost-effective.

The Coldplay Cryoballoon Focal Ablation Systems eliminates the need for precise sizing, multiple deployment steps, and controller units.