MAUDE Adverse Event Report: CSA MEDICAL, INC. TRUFREEZE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	20-00184
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter used for the ablation broke after the 2nd treatment.

• Brand Name: TRUFREEZE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): CSA MEDICAL, INC.; 131 hartwell ave; lexington MA 02421
• MDR Report Key: 12202304
• Report Number: 12202304
• Device Sequence Number: 11522179
• Product Code: GEH
• UDI-Device Identifier: 00857068006105
• UDI-Public: (01)00857068006105
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/02/2021
• Report Date (Section F): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20-00184
• Device Catalogue Number: 20-00184
• Device Lot Number: 0526
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/02/2021