MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; UNIT, CRYOSURGICAL, ACCESSORIES

Catalog Number	CFX2000
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 18 events were reported for this quarter.Product return status: 8 devices were received.10 devices had investigation types that have not yet been determined.Additional information: 18 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 18 events for the failure: free or unrestricted flow.17 events had no health consequences or impact.1 event had problem identified before clinical use/exposure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report#: 3006345872-2025-99001.Supplemental rationale: corrected data: b5, h6, h11.15 previously reported events were included in this follow-up record.Product return status: 1 device investigation type has not yet been determined.7 devices were not available for evaluation.7 devices were received.Evaluation findings (results/components): 1 device: results pending completion of investigation / part/component/sub-assembly term not applicable.7 devices: no findings available / part/component/sub-assembly term not applicable.1 device: manufacturing process problem identified, fatigue problem / balloon, membrane, adhesive.6 devices: manufacturing process problem identified / membrane, adhesive.Product disposition: 7 devices: scrapped by customer.7 devices: scrapped by stryker.1 device: product disposition is not yet determined.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30 2025.This report summarizes 15 events for the failure: free or unrestricted flow.15 events had no health consequences or impact.
Event or Problem Description
No change.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3006345872-2025-99001.Supplemental rationale.Corrected data: b5, h6, h11.15 previously reported events were included in this follow-up record.Product return status.8 devices were not available for evaluation.7 devices were received.Evaluation findings (results/components).8 devices: no findings available / part/component/sub-assembly term not applicable.1 device: manufacturing process problem identified, fatigue problem / balloon, membrane, adhesive.6 devices: manufacturing process problem identified / membrane, adhesive.Product disposition.8 devices: scrapped by customer.7 devices: scrapped by stryker.

• Brand Name: CLARIFIX
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22647413
• Report Number: 3006345872-2025-99001
• Device Sequence Number: 15660427
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 15
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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
• Device Catalogue Number: CFX2000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/31/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown